Actively Recruiting
Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
Led by Shenzhen Maternity & Child Healthcare Hospital · Updated on 2022-08-12
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating decision-making in women with asymptomatic small leiomyoma, a condition involving benign uterine tumors. This study aims to understand factors influencing clinical decisions and to develop a patient decision aid tool based on clinical guidelines and evidence-based medicine. The study involves collaboration among designers, doctors, nurses, and patients to improve patient decision-making and reported outcomes. Participants receive one of two communication approaches: traditional discussion with their healthcare providers or a discussion supported by a patient decision aid tool designed to help patients understand treatment options and outcomes. This tool encourages patient involvement in decisions by providing clear information about benefits and risks related to their health status. During the study, patient satisfaction with decision-making will be monitored over 6 to 12 months. Participants and their families are expected to follow up regularly. The study measures how the use of this decision aid tool impacts patient satisfaction and the quality of their treatment decisions, with ongoing assessments to support understanding and adherence.
CONDITIONS
Brief Title
Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of leiomyoma confirmed by imaging (ultrasound or MRI) with no clinical symptoms
- Female aged between 18 and 55 years
- Maximum diameter of a single leiomyoma less than 5 cm and number not exceeding 10 by MRI
- No contraindications for sedation and analgesia
- Patients and their families agree to participate and can follow up on time
You will not qualify if you...
- History of myomectomy, including transabdominal, laparoscopic, or hysteroscopic surgery
- History of connective tissue diseases or radiotherapy, especially abdominal radiotherapy
- Current pregnancy, acute reproductive tract inflammation, or other gynecological benign or malignant diseases like endometriosis or ovarian tumors
- Leiomyoma diameter 5 cm or larger
- Suspected malignant tumor such as sarcoma
- Language communication barriers preventing cooperation with sedation and analgesia
- Abdominal scarring causing sound attenuation over 10 mm on ultrasound
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 months
Participants discuss their condition using traditional communication or a specially designed decision aid tool to help make informed choices about their treatment options.
Visits scheduled as needed for communication and decision-making
Duration - 6 to 12 months
Participants are followed up to assess satisfaction after using the decision aid tools.
Follow-up visits as scheduled
Trial Site Locations
Total: 1 location
1
Shenzhen Maternal and Child Health Hospital
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
Y
Yu Dai, Associate Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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